Biopharma Update on the Novel Coronavirus: May 27
News information is not all-inclusive. Please check back for updates.
FDA Actions
EUA: The FDA issued a EUA for concerns relating to insufficient supply and availability for personal protective equipment (PPE) for use by health care personal. This includes gowns and other apparel such as operating-room shoe covers.
Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 113 individual EUAs have been issued, which includes 100 molecular tests, 12 antibody tests and 1 antigen test.
Diagnostics
As reported by Forbes, the CDC updated guidance and acknowledged an inability to accurately determine if an individual was previously infected with COVID-19 with antibody tests, especially in populations where there is a low prevalence of the coronavirus.
G2 Intelligence, a market research firm focused on clinical diagnostics, issued a report indicating that the “COVID-19 Test Shortage Is Real & Likely to Last through 2020.” Based on collected data, they say as of May 12, 2020, 9,637,930 tests were performed in the U.S., 1,360,705 were positive and 8,277,225 were negative. But daily test volumes are growing dramatically.
Testing Therapies, Antivirals and Vaccines
Arcturus Therapeutics announced new supportive preclinical data, providing evidence for an adaptive immune response data from the company’s COVID-19 vaccine program, LUNAR-COV19. These new results augment previously disclosed preclinical data demonstrating a strong antibody from the program. Together, the available data indicate that LUNAR-COV19 is effectively activating the two fundamentally important components of the adaptive immune response, providing strong support for human vaccine clinical trials, which are on track to begin this summer.
Organicell Regenerative Medicine announced a positive update on two critically ill COVID-19 patients who were treated at a Georgia hospital with the company’s Organicell Flow product. The patients were treated under Emergency Compassionate Use Investigational authorization from the FDA. The company said the two elderly patients demonstrated a remarkable improvement in their clinical status, lung and renal function confirmed by follow up chest X-rays and lab data. These patients are no longer intubated, are alert and oriented with stable vital signs and oxygenation. Other organs such as the brain, heart and liver commonly affected in patients who had the SARS-CoV-2 virus have all shown progressive improvement in their function.
Company Actions
Diffusion Pharmaceuticals received an accelerated response from the FDA for its Pre-Investigational New Drug (PIND) meeting request seeking guidance on its proposed program for the use of trans sodium crocetinate (TSC) in COVID-19 patients displaying severe respiratory symptoms and low oxygen levels. The FDA’s recommended that the first U.S. TSC COVID-19 study employ a double-blinded, controlled, randomized clinical trial design to address the wide variability in standard of care due to the rapidly evolving COVID-19 experience. The company anticipates enrollment of the first patient in the trial next month.
SCYNEXIS, Inc. is advancing a new antifungal, ibrexafungerp, that can combat deadly drug-resistant fungal pathogens, including invasive pulmonary aspergillosis, which is a concern for severely ill COVID-19 patients. A study conducted in France reported that one-third of intensive care unit patients with COVID-19 had contracted invasive pulmonary aspergillosis.
Ajinomoto Bio-Pharma Services entered into a manufacturing deal with Humanigen for the fill finish supply of lenzilumab, which is in a Phase III trial in adult, hospitalized patients with COVID-19. Under the agreement, Aji Bio-Pharma will provide drug product aseptic fill finish services for Humanigen at its San Diego facility. Lenzilumab is Humanigen’s proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.
Bionano Genomics is participating in Maxim Group’s COVID-19 virtual conference series, “The Role of Cell Therapy and Clarity on Testing” on May 27 at noon, Eastern Time.
Novavax acquired Praha Vaccines, part of the Cyrus Poonawalla Group for $167 million. This deal includes a biologics manufacturing facility and assets in Bohumil, Czech Republic. The facility will provide an annual capacity of more than 1 billion doses of antigen beginning in 2021 for NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.
Other Industry News
Genentech launched a COVID-19 study focused on the underserved minority populations.
As reported by Reuters, the WHO on Tuesday promised a quick review of the data for safety concerns of hydroxychloroquine.
Researchers from Yale University have determined that genetic code found in sewage may be a possible indicator of COVID-19 outbreaks.